Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- •Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- •Subject meets the criteria for presence of Strauss-defined LBBB.
- •Subject meets NYHA classification II or III.
- •Subject is willing and able to provide written consent.
- •Subject is at least 18 years of age at the time of consent.
- •Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
- •The subject's medical records must be accessible by the enrolling site over the follow-up period.
排除标准
- •Subject has documented myocardial infarction before enrollment.
- •Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- •Subject has 2nd or 3rd degree AV block.
- •Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- •Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
- •Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
- •Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
- •Subject underwent valve surgery within 90 days prior to enrollment.
- •Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.
- •Subject is post-heart transplantation or is actively listed on the transplantation list.
- •Subject is implanted with a left ventricular assist device (LVAD).
- •Subject has severe renal disease.
- •Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.
- •Subject has complex and uncorrected congenital heart disease.
- •Subject has life expectancy of less than 12 months.
- •Subject is pregnant or breastfeeding.
- •Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
研究组 & 干预措施
Observational Treatment Arm
干预措施: ICD (Device)
Sequence 1
LBBAP therapy for 6 months followed by LOT-CRT for 6 months
干预措施: LBBAP Therapy (Device)
Sequence 1
LBBAP therapy for 6 months followed by LOT-CRT for 6 months
干预措施: LOT-CRT (Device)
Sequence 2
LOT-CRT for 6 months followed by LBBAP therapy for 6 months
干预措施: LBBAP Therapy (Device)
Sequence 2
LOT-CRT for 6 months followed by LBBAP therapy for 6 months
干预措施: LOT-CRT (Device)
Observational Treatment Arm
干预措施: LOT-CRT (Device)
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: Baseline, 6 months, 12 months
Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
Left ventricular end-systolic volume (LVESV)
时间窗: Baseline, 6 months, 12 months
Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
次要结局
- Left ventricular ejection fraction (LVEF)(Baseline, 6 months)
- Change in LVESV at 6 Months(Baseline, 6 months)
- Left ventricular end-systolic volume (LVESV)(Baseline, 6 months)